International safety notice
Regarding the Terfusion infusion set, which is a component of the kit, the sterilization method of the component supplier has been changed from gamma rays to electron beams. It turned out that it was. As it was discovered that the product was out of scope and could not be combined into a kit, we voluntarily recalled the target product containing the component. I decided to do it.
Japan / PMDA Recalls · JPN · Jun 22, 2021
Key facts
| Title | Regarding the Terfusion infusion set, which is a component of the kit, the sterilization method of the component supplier has been changed from gamma rays to electron beams. It turned out that it was. As it was discovered that the product was out of scope and could not be combined into a kit, we voluntarily recalled the target product containing the component. I decided to do it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Class IV Treatment Kit Sales name: (1) Angio kit (2) General surgery kit (3) Ophthalmology kit (4) Thoracic surgery kit (5) Orthopedic surgery kit (6) Brain surgery kit (7) Urology kit |
| Manufacturer | Hogy Medical Co., Ltd. |
| Models | 13390108DS00, 1439010B0I00, 14390104ON00, 663131299114, 1520451050, 13390104EK00, 660537Z30112, 16321203E500, 16321201RH00, 14390106M700, 15321206IL00, 1420453076 and 118 more |
| Date | Jun 22, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1